bluebird bio Announces Posting of Briefing Documents for Upcoming FDA Advisory Committee

  bluebird bio Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the FDA Cellular, Tissue and Gene Therapies Advisory Committee Meeting to review elivaldogene autotemcel (eli-cel) for early active cerebral adrenoleukodystrophy (CALD) in patients without a matched sibling donor and betibeglogene autotemcel (beti-cel) for the treatment of people with β-thalassemia who require regular red blood cell transfusions.

The advisory committee meeting will take place June 9-10, 2022. Briefing materials, agendas and webcast information for the meeting can be accessed here. The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA.

The Prescription Drug User Fee Act (PDUFA) goal dates for a decision on approval of beti-cel for people with β-thalassemia who require regular red blood cell transfusions and eli-cel for patients with early active CALD without a matched sibling donor are August 19, 2022, and September 16, 2022, respectively.

https://www.biospace.com/article/releases/bluebird-bio-announces-posting-of-briefing-documents-for-upcoming-fda-advisory-committee-meeting/